1. The Field of the Invention
The present invention is directed to skin antiseptic composition applicators, particularly to skin antiseptic composition applicators that include one or more antimicrobial (e.g., antiseptic) materials in a single use applicator. Typically such skin antiseptic applicators are used in preparation for surgery to decolonize the skin prior to surgery and provide some protection to the patient's skin after surgery to prevent infection and aid in the healing process.
2. Description of Related Art
Antiseptic preparation of patient's skin for surgery conventionally includes a two to ten minute scrubbing of the affected area with an antiseptic soap solution followed by the application of a water-soluble antiseptic composition.
These compositions are generally applied with saturated sponges that are attached to a blade or held with forceps. These sponges are often saturated by soaking them in an open pan of antiseptic composition. Sometimes, sponges with attached handles are provided in a plastic or aluminum foil laminate pouch containing enough liquid to saturate the sponge. In some products the sponges are supplied dry in a sterile kit with the antiseptic composition provided in relatively thin walled 4 oz. plastic bottles.
While inexpensive, these techniques are messy and offer little control over inadvertent dripping of the composition into areas where it is undesired. Since many of the available compositions contain active ingredients such as alcohol, iodine or chlorhexidine gluconate, dripping or pooling of such compositions at unintended locations can be irritating when left in contact with the skin. As such, good control over the application has long been desirable, although not always provided.
Skin antiseptic applicator devices have been developed in an attempt to prevent composition dripping associated with the above techniques, and to reduce the time required for application of the antiseptic composition. In particular, the ChloraPrep® products commercially available from CareFusion and the DuraPrep® products commercially available from 3M have enjoyed commercial success by providing substantially drip-free, convenient application of antiseptic compositions compared to the conventional techniques described above.
One of the challenges associated with using such skin antiseptic compositions is the need to sterilize the exterior of the applicator while minimizing potential byproducts that may be produced when the composition is exposed to sterilization compounds such as ethylene oxide gas. Reactive sterilants such as ethylene oxide may react with the active antimicrobial agent or with other components in the skin antiseptic composition, altering the potency or producing potentially toxic compounds.
To address this problem, various solutions have been proposed. For example, the ChloraPrep® applicator, provided by CareFusion, has the active skin antiseptic composition, containing chlorhexidine gluconate (CHG), stored in a breakable glass ampule inside the applicator device. In the ChloraPrep® applicator, the sealed glass ampule protects the CHG composition during the sterilization process from ethylene oxide penetration which could otherwise compromise the efficacy of the antiseptic composition. CareFusion has a number of patents and patent applications including: U.S. Pat. Nos. 5,772,346 and 5,752,363 and U.S. Application Publication No. 2012/003029. Each of these teach the use of a sealed glass ampule containing CHG inside a skin antiseptic applicator.
An alternative solution to this problem is to construct the applicator container walls with layers of materials that are functionally impermeable to ethylene oxide gas. For example, U.S. Application Publication No. 2001/0054562 to Petterson, teaches a sealed medical device with a barrier layer to prevent ethylene oxide penetration by having the applicator walls made of a laminate material having an inner layer of polyolefin, an intermediate layer of silicon oxide and an exterior layer of polyethylene. Similarly, U.S. Pat. No. 8,105,306, assigned to 3M, teaches a skin antiseptic applicator with a container having a first interior layer of a polyolefin material which is impermeable to the liquid and vapor phases, and a barrier layer of polyester adhered to the interior layer which is impermeable to gaseous ethylene oxide. In the 3M applicator, both layers are free of silicon oxide. Another example is U.S. Application Publication No. 2012/184929, assigned to 3M, which teaches a skin antiseptic applicator with a container having a first interior layer which is permeable to the liquid and vapor phases, an adhesive layer for adhering the barrier layer to the interior layer, and a barrier layer which is impermeable to gaseous ethylene oxide.
One recurring problem with such existing skin antiseptic applicators is that the solutions provided to minimize ethylene oxide penetration also add additional cost and complexity to the applicator devices. From a manufacturing perspective, it would be preferable to provide an applicator having a container wall with only one layer (e.g., a homogenous layer) of material, rather than requiring multiple different layers. In addition, to reduce costs and simplify manufacturing of these devices, it would be an improvement to provide an applicator with a single compartment containing the skin antiseptic composition, instead of multiple initially separated compartments, or a sealed glass ampule inside of the applicator container.
One of the challenges associated with these skin antiseptic applicators is that the CHG or similar antiseptic compositions are often not stable with dye components. It is desirable to have a dye of a skin contrasting color along with the skin antiseptic composition, because then the practitioner applying the skin antiseptic composition to the patient and other healthcare providers who subsequently interact with the patient can more readily see where the composition has been applied on the skin. One solution is to provide the CHG composition in a separate compartment from a dye composition. For example, the ChloraPrep® applicators have the CHG composition in a glass ampule and the dye composition is provided in the foam applicator head. In the ChloraPrep® applicator the CHG composition flows through the dye and mixes with the dye in the applicator head. Another example of a two chamber applicator is described in U.S. Pat. No. 8,348,537, assigned to Covidien, which teaches an applicator with side-by-side, initially separate chambers for housing an antiseptic composition in one chamber and a dye in the other chamber. In the Covidien applicator, the dye and the antiseptic composition mix just prior to reaching the applicator head.
One problem with such existing skin antiseptic applicators containing multiple compartments for housing the dye separate from the antiseptic composition is that a multi-chamber applicator increases costs and complexity in the manufacturing process. From a manufacturing perspective, it would be preferable to provide an applicator needing only one compartment. In addition, it is preferable from a use perspective to have the dye and the antiseptic composition as one composition, as then the practitioner does not have to worry about mixing the two compositions together prior to application, and it eliminates the possibility that the antiseptic composition might be delivered to the patient's skin without dye or without sufficient dye to readily indicate to the practitioner where the product has been applied.
In view of the current state of the art, there is a continuing need for improved applicator products.